Extract

Background and study aims Vascular dementia is the second most common form of dementia, affecting an estimated 20% of people with dementia and accounting for approximately 7 million people worldwide. It is caused by problems with the blood supply to the brain, for example following a stroke or due to damage to the tiny blood vessel network in the brain. The resulting damage causes cells to be lost, leading to the development of dementia. The most common form of vascular dementia is subcortical ischemic vascular dementia (SIVD), affecting up to 67% of people with vascular dementia. To date there has been minimal investment in treatments for people with vascular dementia despite the large number of people affected by the condition. As a result there are no drugs licensed for the treatment of vascular dementia and no ongoing clinical trials. The aim of this study is to investigate whether treatment with the calcium channel blocker medication amlodipine can improve outcomes for people with SIVD. The study will compare amlodipine treatment with a control to see if there is any difference compared to the care people usually receive. Who can participate? We aims to recruit 588 patients aged 50 years or over with SIVD. What does the study involve? Patients will be randomly allocated to one of two groups and neither the patients nor the clinicians will know which group someone has been allocated to: usual care + amlodipine or usual care + dummy drug (placebo). Patients will be required to take either amlodipine or placebo: 5 mg once daily for 2 weeks followed by 10 mg once daily for 50 weeks. Patients will be enrolled in the study for 2 years; 1 year on treatment and a follow up telephone call at the end of year 2. Patients will undergo an MRI brain scan at the screening stage of the study to confirm diagnosis and also after 1 year to monitor progress. During the study, patients with an informant (friend, relative or professional carer) will be asked to attend the clinic at various intervals and both will be asked to complete questionnaires with the help of an assessor. The study will measure changes in mental speed and executive function (overall cognition), detect changes in ability to perform everyday tasks, further symptoms of dementia and caregiver burden. Tools will also be used to measure the cost-effectiveness of the treatments. What are the possible benefits and risks of participating? Participants may see an improvement in their dementia symptoms. This will be the first large scale treatment study in people with vascular dementia. There have been no study of this size and there are no studies currently registered. Amlodipine is already licensed for use in the UK; therefore if the results of this trial are successful amlodipine could quickly be made available as a treatment for vascular dementia. Amlodipine is a licensed drug but, as with all drugs, there are side effects associated. The most common side effects include headache, oedema, flushing, dizziness, ankle swelling, fatigue, nausea, and rash. Side effects will be monitored by the study team throughout the trial. Where is the study run from? The study will take place across sites in the UK. The trial co-ordinating centre is the Northern Ireland Clinical Trials Unit (NICTU) and the lead centre will be The Belfast Health and Social Care Trust (UK). When is the study starting and how long is it expected to run for? Recruitment is expected to start in October 2014 and will run for 2 years. Who is funding the study? Funding has been provided equally by the Alzheimer's Society and the British Heart Foundation (UK). Who is the main contact? Professor Peter Passmore [email protected]

Inclusion criteria

• Subcortical ischaemic vascular dementia

Links

• ictrp
• isrctn